RESEARCH TRIANGLE PARK, N.C., May 10 /PRNewswire/ -- Quill Medical, Inc. today announced that it has received CE Marking for its Quill(TM) Barbed Polydioxanone Suture, used in dermal closure. The CE Mark allows Quill Medical to market its Barbed Polydioxanone Sutures throughout Europe. The product is first in a series of tissue repair devices based on a proprietary technology that enables sutures to "self-anchor" in tissue without the need for a conventional suture knot.
"Devices that eliminate the painstaking step of suture knot-tying would benefit nearly all fields of surgery," said Matthew Megaro, Quill Medical President and CEO. He added, "We are developing a range of such products for use in many specialized and commercially important surgical applications."
This CE Mark approval resulted from the review and evaluation of technical and clinical data developed through multi site testing of the Barbed Polydioxanone Suture. CE Marking on a product is a manufacturer's declaration that the product complies with essential health and safety requirements for marketing and distribution throughout the 25 countries that comprise the European Union.
About Quill Medical
Quill Medical is a North Carolina-based medical device company developing innovative surgical aids based on its novel and proprietary knot-less, self- anchoring suture technology. The company's products target diverse applications in the fields of wound closure, orthopedic and cosmetic surgery. For more information, visit http://www.quillmedical.com/ .
About TUV America Inc. (Medical Unit)
TUV America Inc., Product Service division, is a leading EU Notified Body for the Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Directives. TUV also provides ISO 9000, ISO 13485/88, EN 46000 and ISO 14001 certification; SCC qualified ISO 13485 Registrar for the Canadian Medical Devices Regulations; FDA 510(k) reviews; electromagnetic compatibility (EMC); NRTL certification to ANSI/UL 2601; electrical, mechanical and functional safety testing; and many additional global conformity assessment services. Globally, TUV has issued over 130,000 product and 12,000 quality management system certifications. For more information, visit http://www.tuvamerica.com/ .
Quill Medical, Inc.
CONTACT: Matthew Megaro, President and CEO of Quill Medical, Inc.,+1-919-806-1961